Onanon, Inc
720 South Milpitas Blvd, Milpitas, CA, US
Registered product codes
7 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3010086866.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Apr 21, 2026
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Apr 21, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
5 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17Lack of Written MDR Procedures
1ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
1ISO 13485:2016 Clause 7.4.1Supplier monitoring and re-evaluation not planned
1ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
1ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained
1
- 21 CFR 803.17Apr 21, 2026
Lack of Written MDR Procedures
- ISO 13485:2016 Clause 7.1Apr 21, 2026
Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.4.1Apr 21, 2026
Supplier monitoring and re-evaluation not planned
- ISO 13485:2016 Clause 8.2.2Apr 21, 2026
Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 8.3.1Apr 21, 2026
Records of nonconforming product and actions taken not maintained
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.